BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 19257807 · Received May 7, 2024

    Report

    Report Number
    1119421-2024-00861
    Event Type
    Injury
    Date Received
    May 7, 2024
    Report Date
    May 7, 2024
    Manufacturer
    ALCON RESEARCH, LLC - HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE LITERATURE REPORT DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. THE ROOT CAUSE FOR THE REPORTED NEGATIVE DYSPHOTOPSIA CANNOT BE DETERMINED. A MALFUNCTION HAS NOT BEEN INDICATED AGAINST THE PRODUCT. THE COMPLAINT WAS OPENED FROM A LITERATURE REPORT: EVALUATION OF A NEW DEVICE TO TREAT NEGATIVE DYSPHOTOPSIA. THIS WAS TO EVALUATE THE EFFICACY AND SAFETY OF NEGATIVE DYSPHOTOPSIA (ND) RING IMPLANTATION FOR TREATING AND PREVENTING ND. THERE CAN BE A GAP IN THE PERIPHERAL RETINAL IMAGE BETWEEN THE LIGHT RAYS THAT MISS THE OPTIC OF THE IOL AND THE RAYS THAT ARE REFRACTED, ALONG WITH POOR TRANSMITTANCE OF LIGHT AT HIGH INCIDENCE ANGLES BY THE ANTERIOR NASAL RHEXIS, LEADING TO NEGATIVE DYSPHOTOPSIA (ND). THIS FILE IS FOR CASE 6 (COMPANY MODEL), WHO HAD A COMPLETE RESOLUTION OF SYMPTOMS RELATED TO ND AFTER INSERTION OF THE RING. LITERATURE CITATION: PRAKHYAT ROOP, ET AL., EVALUATION OF A NEW DEVICE TO TREAT NEGATIVE DYSPHOTOPSIA, JOURNAL OF CATARACT AND REFRACTIVE SURGERY. FEB2024, VOLUME 50 (2), 122-127 THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    THE RESEARCH ARTICLE WAS PUBLISHED WITH PURPOSE OF TO EVALUATE THE EFFICACY AND SAFETY OF NEGATIVE DYSPHOTOPSIA (ND) RING IMPLANTATION FOR TREATING AND PREVENTING ND. THE STUDY WAS CONDUCTED IN 22 PATIENTS WITH ND WERE ENROLLED. EYES WITH OTHER OCULAR STRUCTURAL PATHOLOGIES (CORNEAL, MACULAR, OPTIC NERVE HEAD, RETINAL, NEURO-OPHTHALMOLOGICAL) WERE EXCLUDED. IN 15 EYES, THE RING WAS IMPLANTED TO TREAT ND (THERAPEUTIC GROUP), AND IN 7 EYES, IT WAS IMPLANTED DURING CATARACT SURGERY OF THE FELLOW EYE AS A PROPHYLACTIC MEASURE (PROPHYLACTIC GROUP) TO PREVENT THE OCCURRENCE OF ND. PREOPERATIVE EVALUATION INCLUDED VIDEO RECORDING OF THE PATIENTS¿ COMPLAINTS ASIDE COMPLETE EYE EXAMINATION. POSTOPERATIVELY, PATIENTS WERE INTERVIEWED TO CONFIRM RESOLUTION OF COMPLAINTS RELATED TO ND. THE INTRAOPERATIVE DIFFICULTIES AND POSTOPERATIVE ADVERSE EVENTS WERE RECORDED. A MINIMUM FOLLOW-UP OF 1 YEAR WAS COMPLETED FOR ALL EYES. THE STUDY RESULTS STATED THAT THE THERAPEUTIC GROUP, 14 OF 15 EYES (93.3%) PATIENTS REPORTED COMPLETE RESOLUTION OF ND ON THE FIRST POSTOPERATIVE DAY WHILE 1 PATIENT REPORTED PERSISTENCE OF A SMALLER AND LIGHTER TEMPORAL SHADOW. NO ND WAS REPORTED BY ANY PATIENT IN ANY OF THE 7 EYES TREATED PROPHYLACTICALLY. NO SIGNIFICANT ADVERSE INTRAOPERATIVE EVENT WAS RECORDED; HOWEVER, VITREOUS UPTHRUST WAS NOTED IN 2 OF 22 EYES (9.0%). NO PERMANENT DROP IN VISUAL ACUITY WAS RECORDED IN THE THERAPEUTIC GROUP. THE STUDY WAS CONCLUDED WITH ND RING IMPLANTATION WAS AN EASY, SAFE, AND EFFECTIVE APPROACH FOR BOTH TREATING AND PREVENTING ND. THIS FILE BELONGS TO A MALE PATIENT OF AGE 48 YEARS POST IMPLANTATION OF INTRA OCULAR LENS(IOL), PATIENT HAD DARK SHADOW ON THE TEMPORAL SIDE. THE RING WAS IMPLANTED TO TREAT NEGATIVE DYSPHOTOPSIA. THE SYMPTOMS WAS RESOLVED TO THE PATIENT. THERE ARE (B)(4) MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 4 OF 9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670555 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON RESEARCH, LLC - HUNTINGTON SN60WF ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Required Intervention